The study, Medical Device Development: Benchmarking Early-Stage Product Management and Promotion, reveals that the majority of surveyed medical device manufacturers report using either pre-market approval or a 510(k) clearance pathway. And although companies' chosen regulatory pathways are technically independent of the device class, there is a correlation between the two.

On average, Class 2 devices trend toward 510(k) approval while Class 3 products often require PMA submissions. For Class 2 devices, 65% of surveyed device manufacturers report using a 510(k); 19% report pre-market approval. Aside from the half of the surveyed device companies that look to PMAs for regulatory approval of Class 3 devices. another 31% use 510(k) with clinical trials to support product approval; only 13% report using a 510(k) sans clinical trials.

"While medical device manufacturers can choose from multiple regulatory registration options, selecting the best-fit pathway can be challenging," said Adam Bianchi, senior director of research at Cutting Edge Information. "This process can be especially difficult for start-up companies, which have little to no experience with the marketplace."

The study found that the majority (75%) of surveyed Top 50 manufacturers use 510(k) for Class 2 devices. However, for supported Class 3 devices, 20% of surveyed Top 50 manufacturers use 510(k), and another 20% use 510(k) with clinical trials to gain approval. The surveyed small device companies more commonly look to 510(k) with clinical trials compared to larger companies. These small manufacturers are also the only companies to report using other regulatory pathways.

Medical Device Development: Benchmarking Early-Stage Product Management and Promotion, available at https://www.cuttingedgeinfo.com/product/medical-device-development/, explores the resources and best practices necessary to support new product planning and commercialization for US-based medical device launches. This benchmarking study, conducted through primary research, includes:

Profiles of medical device firms and their products, highlighting human and financial resources supporting development and commercialization, product development timelines and expected commercial success.

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